COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On July 23, 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of Sanofi-Aventis Australia Pty Ltd gave consent to:
the importation and supply, of
frusemide (LASIX) 10 mg/mL oral liquid bottle [AUST R 12405] that does not conform with the requirements of the clauses 3 & 8 of the Therapeutic Goods Order No. 77- Microbiological Standards for Medicines in that the product does not meet the minimum microbiological requirements with which a medicine must comply throughout its shelf life (clause 3 of the Order); and the product, which is a multidose medicine, does not fully comply with the British Pharmacopoeia, Appendix XVI C. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3) (clause 8 of the Order).
The consent is effective from July 23, 2014 until March 31, 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- Batches of product not yet manufactured will be supplied labelled with the reduced shelf life of 18 months during the period of this s14 consent, as agreed in your email of 21 July 2014.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the quality, efficacy, and safety of therapeutic goods in Australia, addressing gaps in public health protection by providing a legal framework for the oversight and control of therapeutic goods. The Act is administered by the Therapeutic Goods Administration (TGA), an agency within the Australian Government's Department of Health. The policy objective of the Act is to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy, thereby protecting public health. On July 23, 2014, the delegate of the Secretary for the Department of Health granted consent to Sanofi-Aventis Australia Pty Ltd for the importation and supply of a specific product, frusemide (LASIX) 10 mg/mL oral liquid bottle, which did not fully conform to microbiological standards and antimicrobial preservation efficacy requirements. This consent, effective from July 23, 2014 until March 31, 2015, was subject to conditions including the labelling of batches with a reduced shelf life to mitigate identified compliance issues.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods within Australia, encompassing a wide range of products including medicines, medical devices, and blood and blood components. The Act applies to entities and individuals involved in the supply, importation, and manufacture of these goods, ensuring that they meet safety, quality, and efficacy standards. The Act's jurisdiction is Commonwealth-wide, meaning it applies across Australia. However, certain aspects of the Act may be subject to additional state or territory laws. The Act provides for various exclusions and exemptions, particularly for research and clinical trials under specific conditions. Section 14 and 14A of the Act allow for consent to be granted for goods that do not fully comply with certain standards, subject to specific conditions as outlined by the Secretary’s delegate, such as labelling or limited distribution to control potential risks. This legislation is further administered through subordinate instruments, including regulations and orders, which provide detailed requirements and standards for therapeutic goods.
Key Provisions
The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, allows the delegate of the Secretary of the Department of Health to provide consent for the importation and supply of therapeutic goods that do not fully comply with certain standards. In this instance, Sanofi-Aventis Australia Pty Ltd applied for and received consent for the importation and supply of frusemide (LASIX) 10 mg/mL oral liquid bottle [AUST R 12405], which does not meet the microbiological standards outlined in clauses 3 and 8 of Therapeutic Goods Order No. 77. This consent is effective from 23 July 2014 to 31 March 2015.
The obligations placed on Sanofi-Aventis Australia Pty Ltd under this consent include ensuring that any batches of the product not yet manufactured are labelled with a reduced shelf life of 18 months. This obligation is in line with the conditions set by the delegate of the Secretary and agreed upon in an email dated 21 July 2014. The consent also mandates adherence to the specified timeframe, ensuring that the supply of non-compliant products is limited to the period mentioned.
Breaching the conditions set forth in the consent may result in civil or criminal consequences. Although specific offences and penalties are not detailed in the notice, under the Therapeutic Goods Act 1989, general provisions include potential fines, imprisonment, or both. The exact penalties would depend on the severity of the breach and any additional legal considerations. It is important for Sanofi-Aventis Australia Pty Ltd to comply strictly with the terms of the consent to avoid any legal repercussions.